drugset / Trial / NCT02812667

Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT02812667

NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an effect on cancer and body in combination with nivolumab, a standard treatment for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that is not approved for use outside of research studies by regulatory agencies. Up to 38 patients will be enrolled.

Timeline

Start
2016-08-29
Primary completion
2024-11-24
Completion
2025-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Plinabulin Small molecule 3.5 mg/m2 Intravenous
Subject Plinabulin Small molecule 20 mg/m2 Intravenous
Subject Plinabulin Small molecule 30 mg/m2 Intravenous
Subject Plinabulin Small molecule 40 mg/m2 Intravenous
Background Nivolumab Monoclonal antibody 240 mg Intravenous